Safety and Efficacy Study of IPG Patient With Home Monitoring

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-02-29

Brief Summary

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The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.

The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.

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Detailed Description

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Patients will be randomized into HM follow-up only (Group 1) or HM \& in-office follow-up (Group 2) and will be followed-up for 27 months.

Conditions

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Bradyarrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home Monitoring(HM)

Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.

Group Type EXPERIMENTAL

BIOTRONIK Home Monitoring System

Intervention Type DEVICE

Home Monitoring system transfers implantable device's data to the main server via internet.

Control

Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.

Group Type ACTIVE_COMPARATOR

BIOTRONIK Home Monitoring System with In-office Follow-up

Intervention Type DEVICE

Interventions

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BIOTRONIK Home Monitoring System

Home Monitoring system transfers implantable device's data to the main server via internet.

Intervention Type DEVICE

BIOTRONIK Home Monitoring System with In-office Follow-up

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indicated for IPG implantation under Japanese guidelines
* Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
* Able to utilize HM system throughout the study
* Ability to give informed consent
* Geographically stable and able to return for follow-ups for 27 months
* Over 20 years old
* Patient able to understand and follow the procedure stated in protocol

Exclusion Criteria

* Contraindicated for IPG under Japanese guidelines
* Patients who are currently included in another cardiac clinical study
* Patients with expected life period of less than two years
* Patients who might undergo heart transplantation in next two years.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No